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2016 Launch for FluChip-8G

By on October 7, 2014

Potential tests to help doctors diagnose influenza sooner and more accurately will advance in development under contracts from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). The tests could help boost influenza pandemic preparedness by increasing diagnostic capabilities in near-patient care settings such as doctors’ offices, clinics, and hospitals.

One award will advance the development of a simple, low-cost molecular test under a 3.5-year, $12.9 million contract with Alere Inc., headquartered in Waltham, Massachusetts. The other award, to InDevR Inc., of Boulder, Colorado, will allow a biochip test to move forward under a two-year, $7.9 million contract with options to extend the contract up to $14.7 million over four years.

The tests use different technologies to detect influenza viruses and offer different levels of information about the viruses detected. Both tests would use swabs taken from a patient’s nasal passage.

Alere will develop its iNAT Influenza A&B test which could yield results within 15 minutes and show whether a patient has an infection caused by a seasonal influenza virus type A or B infection. The company will conduct studies necessary to submit for U.S. Food and Drug Administration clearance or approval, including a Clinical Laboratory Improvement Amendments waiver for iNAT, which would allow the rapid molecular test to be performed in the near-patient settings.

InDevR will develop its FluChip-8G test to identify seasonal influenza viruses and recognize novel flu viruses within four hours in near-patient settings. Currently, this type of detailed genetic testing is conducted in state, federal, or specialty laboratories, and can take days to complete. If successful during the first two years, InDevR will conduct clinical studies necessary to submit for clearance or approval from the FDA and will develop a fully automated version of the test.